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QA Compliance Lead (m/f/d)

Novartis -
Stein, AG

Jetzt bewerben

Details zur Stelle

100% | Pensum: 90-100%

Leistungen

Unterkunft

Qualifikationen

Biotechnologie
Englisch
Qualitätssicherung
Bachelor
Qualitätssysteme
Deutsch

Vollständige Stellenbeschreibung

Summary

Location: Stein, Switzerland

We are seeking a highly senior Quality Assurance Compliance leader to safeguard and continuously strengthen our GMP compliance landscape in Switzerland. This role is designed for an experienced quality authority who brings deep regulatory credibility, strategic oversight, and confident leadership in complex, regulated environments.

About the Role

Key responsibilities:

Provide overall leadership and strategic oversight of Quality Compliance activities across the site in line with cGxP requirements
Act as the senior quality authority for audits, inspections, and health authority interactions, ensuring sustained inspection readiness
Own and continuously develop the Quality Management System (QMS), including deviations, CAPAs, change control, and data integrity
Lead and govern GxP risk management, incident management, and compliance remediation activities
Ensure effective regulatory and quality oversight of site activities, suppliers, and service providers
Drive a strong quality culture, serving as a role model for integrity, accountability, and patient focus
Partner closely with senior stakeholders across Manufacturing, Technical Operations, Regulatory, and Global Quality
Coach and develop senior quality professionals, ensuring sustainable expertise and succession within the organization
Champion Lean Leadership and operational excellence initiatives.

Essential Requirements:

Minimum 15 years of progressive experience in Quality Assurance and Compliance within a GMP‑regulated pharmaceutical or biotech environment
Proven track record in senior QA leadership roles, with clear accountability for compliance strategy and inspection outcomes
Deep expertise in cGMP, Quality Systems, and regulatory frameworks (EMA, FDA, Swissmedic)
Extensive experience leading health authority inspections, audits, and complex remediation programs
Strong credibility and executive presence when interacting with senior internal and external stakeholders
Demonstrated ability to lead, influence, and challenge at senior management level
University degree in Life Sciences, Pharmacy, Chemistry, Biotechnology, or a related discipline
Fluent in English; German is a strong advantage for Switzerland

Benefits & Rewards

Commitment to Diversity and Inclusion / EEO paragraph

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Accessibility and Accommodation:

Applicable Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)

Division

Operations

Business Unit

Quality

Location

Switzerland

Site

Stein Aargau

Company / Legal Entity

C046 (FCRS = CH046) Novartis Pharma Stein AG

Functional Area

Quality

Job Type

Full time

Employment Type

Regular

Shift Work

Jetzt bewerben

Erweiterte Suche

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